Jackson Andrew, MacPherson Hugh, Hahn Seokyung
Northern College of Acupuncture, York, UK.
Complement Ther Med. 2006 Mar;14(1):39-46. doi: 10.1016/j.ctim.2005.07.005. Epub 2005 Sep 19.
To explore patient perceived benefits of acupuncture for tinnitus.
Controlled n=1 trials, with two phases A and B.
Six patients with tinnitus.
Primary outcome was Daily Diary records related to four tinnitus symptoms: loudness of tinnitus; pitch of tinnitus; waking hours affected with tinnitus; quality of sleep. Secondary outcomes were the Tinnitus Handicap Inventory (THI) and Measure Your Medical Outcome Profile (MYMOP).
Patients received a course of 10 acupuncture treatments over a 2-week period. Daily Diary entries related to the four tinnitus symptoms were recorded by patients for 14 days pre-treatment (phase A) and 14 days post-treatment (phase B). A hierarchical Bayesian model was used to combine the results from the individual patients to obtain estimates of the population and individual patient treatment effects, incorporating random variations at both levels (between patients and within patient). Tinnitus Handicap Inventory (THI) and Measure Your Medical Outcome Profile (MYMOP) were recorded at assessment points pre-treatment and post-treatment.
Six patients participated in the trials, each receiving 10 treatments and completing all Daily Diary entries and outcome measures. For the of symptoms of loudness and pitch, there were variable treatment effects between patients, with a trend for the median overall reduction for loudness of -2.49 (-5.04, 0.02) and for pitch -1.39 (-3.74, 0.89), 95% credibility intervals being shown in brackets. For the other two symptoms, the waking hours affected and quality of sleep, patients' responses were more consistent, with amore credible overall median reduction for affected waking hours of -2.76 (-3.94, -1.63) and for quality of sleep -2.72 (-3.45, -2.03). The THI and MYMOP measures showed a trend of improvement after treatment.
The n=1 trial methodology, with an AB design and Bayesian analysis, can be considered of value in exploring treatment effects for small numbers of patients receiving individualised treatments, as is common within complementary medicine. When the treatment effects from six patients were synthesized, the results of this study suggest that acupuncture may have a beneficial role in the treatment of tinnitus.
探讨患者对针灸治疗耳鸣的感知益处。
采用n = 1的对照试验，分为A、B两个阶段。
6名耳鸣患者。
主要观察指标为与四种耳鸣症状相关的每日日记记录，即耳鸣响度、耳鸣音调、受耳鸣影响的清醒时间、睡眠质量。次要观察指标为耳鸣障碍量表（THI）和医疗结局自我评估量表（MYMOP）。
患者在2周内接受10次针灸治疗。患者在治疗前14天（A阶段）和治疗后14天（B阶段）记录与四种耳鸣症状相关的每日日记条目。使用分层贝叶斯模型将个体患者的结果进行合并，以获得总体和个体患者治疗效果的估计值，同时考虑两个层面的随机变异（患者之间和患者内部）。在治疗前和治疗后的评估点记录耳鸣障碍量表（THI）和医疗结局自我评估量表（MYMOP）。
6名患者参与了试验，每人接受10次治疗，并完成了所有每日日记条目和观察指标。对于响度和音调症状，患者之间的治疗效果存在差异，响度总体中位数下降趋势为-2.49（-5.04，0.02），音调为-1.39（-3.74，0.89），括号内为95%可信区间。对于另外两个症状，即受影响的清醒时间和睡眠质量，患者的反应更为一致，受影响的清醒时间总体中位数下降更可信，为-2.76（-3.94，-1.63），睡眠质量为-2.72（-3.45，-2.03）。THI和MYMOP测量结果显示治疗后有改善趋势。
n = 1试验方法，采用AB设计和贝叶斯分析，对于探索接受个体化治疗的少数患者的治疗效果可能具有价值，这在补充医学中很常见。当综合6名患者的治疗效果时，本研究结果表明针灸可能在耳鸣治疗中发挥有益作用。
